MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G124

Device Problems Over-Sensing (1438); Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/12/2024

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered anti-tachycardia pacing (atp) for ventricular fibrillation (vf) which was unsuccessful and resulted in undersensing of the vf amplitude signal.This arrhythmia is then redetected in the vt-1 zone, where six atp are programmed.The first atp in this scheme is unsuccessful with a shock egm that appears to show this arrhythmia degenerating into vf.The subsequent five atp were unsuccessful in the presence of vf and a 41 joule shock was delivered which successfully converted this arrhythmia.The crt-d remains in service and there were no adverse patient effects reported.Additional information provided from the field indicated the patient was admitted to the hospital for defibrillation threshold (dft) testing.Prior to dfts, cross-talk oversensing was observed with the atrial signal being picked up on the ventricular channel.Atrial sensing parameters had to be adjusted as well.X-rays taken did not reveal any anomalies with the system.Dfts were performed with a shock converting the patient successfully, with in-range measurements.The crt-d was reprogrammed and remains in service.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19040894
• MDR Text Key: 339373245
• Report Number: 2124215-2024-20547
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2019
• Device Model Number: G124
• Device Catalogue Number: G124
• Device Lot Number: 488530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR